PROTECTION OF HUMAN SUBJECTS
Sections
14.01.04 Special Protections for Pregnant Women, Fetuses, Prisoners, and Children; Special Rules for Transplantation of Fetal Tissue and Xenotransplantation into Human Subjects; and Moratorium on Research Involving Human Cloning and Embryo Research
14.01.05 Responsibilities and Delegations of Authority
Appendix A - Sample Exemption Memorandum
Appendix B - Information Needed for Research Proposal to the NIST Institutional Review Board
Appendix C - Requirements for Informed
Consent Form
14.01.01
PURPOSE
The National Institute of Standards and Technology conducts and supports
research in which human subjects are involved. This subchapter states the
policies and procedures to be followed in obtaining approval to conduct
or support research involving human subjects.
14.01.02
SCOPE
This subchapter applies to all research involving human subjects conducted
or supported by NIST-Gaithersburg or NIST-Boulder. The term "research involving
human subjects" is broad, encompassing the study of human behavior, reactions,
and thought processes as well as the tangible study of the human body,
tissues, organs, cells, and so on. "Research" means a systematic investigation,
including research development, testing and evaluation, designed to develop
or contribute to generalizable knowledge. Activities which meet this definition
constitute research for purposes of this subchapter, whether or not they
are conducted or supported under a program which is considered research
for other purposes. For example, human testing of computer software, research
involving human cells or tissue, and in certain limited circumstances even
employee surveys may fall within the scope of this subchapter. Research
"conducted or supported" by NIST is broadly interpreted. In addition to
research carried out by NIST employees and NIST contractors and funding
recipients, the term includes activities of foreign and domestic guest
researchers under their agreements with NIST, outside parties utilizing
NIST facilities, and activities carried out jointly by NIST and other parties
in shared facilities such as the Center for Advanced Research in Biotechnology
(CARB) and JILA, and in CRADAs.
14.01.03
POLICY
As an agency of the U.S. Department of Commerce, NIST may only conduct
or support research involving human subjects in accordance with 15 CFR
Part 27, the Common Rule for Protection of Human Subjects. To adhere to
the policy stated in 15 CFR Part 27, NIST has adopted the following procedures
for obtaining approval to conduct or support research involving human subjects.
14.01.04
SPECIAL PROTECTIONS FOR PREGNANT WOMEN, FETUSES, PRISONERS, AND CHILDREN;
SPECIAL RULES FOR TRANSPLANTATION OF FETAL TISSUE AND XENOTRANSPLANTATION
INTO HUMAN SUBJECTS; AND MORATORIUM ON RESEARCH INVOLVING HUMAN CLONING
AND EMBRYO RESEARCH
a. At the time of the adoption of this subchapter, regulations have
been adopted by the National Institutes of Health (NIH) governing research
conducted or supported when certain classes of human subjects are involved,
including pregnant women, fetuses and fetal tissue, prisoners, and children;
further, the Food and Drug Administration (FDA) has adopted guidelines
concerning xenotransplantation into human subjects. In addition, the Congress
has enacted laws governing the transplantation of fetal tissue into human
subjects when NIH funding is involved and, in response to a Presidential
ban on the use of federal funding for human cloning, a prohibition on NIH
funding of human cloning research. NIST is not directly named in these
statutes and regulations, and as a literal matter of law may not be regulated
by them. In order to assure that research conducted or supported by
NIST in these fields is consistent with national policy, NIST hereby declares
that it will fully adhere to all current and future statutory requirements
imposed upon NIH and other federal agencies on these topics, all current
and future regulatory policies adopted by NIH, FDA, and other federal agencies
on these topics, and all current and future Presidential statements of
policy on these topics.
b. Consistent with the policy stated above:
(1) All research projects conducted or supported by NIST involving protected
classes of human subjects as defined in NIH regulations found at 45 CFR
Part 46, Subparts B, C, and D, including fetuses, pregnant women, human
in vitro fertilization, prisoners, and children, must be reviewed and approved
by an Institutional Review Board (IRB) outside of NIST that NIST has verified
in writing to possess a current assurance, appropriate for the research
in question, on file with the NIH Office of Protection from Research Risks
(OPRR) of the Department of Health and Human Services, and which has been
approved by OPRR for federalwide use. Consistent with the requirements
of Subpart B of the NIH regulations, no grant, contract or cooperative
agreement may be awarded by NIST, nor any other formal or informal agreement
executed, for research involving fetuses, pregnant women, or human in vitro
fertilization until the IRB review has been completed, and all other requirements
of this subchapter have been met.
(2) Research projects involving the transplantation of fetal tissue
into human subjects must be carried out in accordance with the requirements
of section 111 of the NIH Revitalization Act of 1993 (42 U.S.C. 289g-1.)
(3) Human fetal research must be carried out in accordance with Section
498(b) of the Public Health Service Act (42 U.S.C. 289g.)
(4) Human embryo research must be carried out in accordance with any
authorization or appropriations laws applicable to the Department of Health
and Human Services, e.g., Section 513 of Public Law 105-78.
(5) In addition to the requirements that NIST is adopting as a matter
of policy, the NIH Revitalization Act of 1993 contains a criminal statute
prohibiting all purchases of fetal tissue for valuable consideration, whether
or not NIH or NIH funding is involved (42 U.S.C. 289g-2.) Thus, any and
all relevant activities involving NIST are covered by this statute.
(6) NIST will observe the prohibition on federal funding of research
involving human cloning and any future Presidential directive for federal
funding in these areas.
c. All documents referenced in this section are available in the Office
of the Deputy Chief Counsel.
14.01.05
RESPONSIBILITIES AND DELEGATIONS OF AUTHORITY
a. NIST employees and their appropriate line management, and
guest researchers (foreign and domestic), their hosts, and their hosts'
appropriate line management, are responsible for submitting to their OU
Directors protocol descriptions for research projects they would like to
conduct or support that involve human subjects.
b. OU Directors are hereby delegated responsibility and authority
for determining whether research projects involve human subjects that fall
into a class of subjects covered by 45 CFR Part 46, Subpart B, C, or D
and for determining in writing whether research projects involving human
subjects fall within one of the exemptions to the Common Rule as stated
in 15 CFR 27.101(b). OU Directors may seek the advice of the NIST IRB Chairperson
in making these determinations. In the case of research projects involving
contracts, grants, or cooperative agreements, OU Directors shall coordinate
with the NIST Deputy Chief Counsel and the Office of the General Counsel's
Office of Finance and Litigation in making exemption determinations. The
determinations shall be made with the written approval of the NIST Deputy
Chief Counsel and shall be submitted to the NIST IRB Chairperson with copies
to other interested parties. No exemptions are available for research involving
human subjects that is conducted under 45 CFR Part 46 Subpart B, C, or
D. (A sample exemption memorandum is included as Appendix A to this subchapter.)
c. Chief, Acquisition and Assistance Division, for all contracts,
grants, and cooperative agreements that involve human subjects research;
the Chief, Finance Division, for all 1525 agreements and other formal
or informal agreements processed through the Finance Division that involve
human subjects research; the Director, Office of Technology Partnerships,
for all CRADAs, domestic guest researcher agreements, and other formal
or informal agreements processed through the Industrial Partnerships Program
that involve human subjects research; and the Director, Office of International
and Academic Affairs, for all foreign guest researcher agreements that
involve human subjects research: (1) verify that appropriate documentation
of reviews and clearances have been provided before agreements are executed;
(2) ensure that all agreements contain award terms and conditions to ensure
that projects remain in compliance with 15 CFR Part 27; (3) retain appropriate
records documenting IRB approvals, granting of exemptions, and so on.
d. NIST IRB approves, disapproves, or seeks modification to internal
research projects, including those of domestic and/or foreign guest researchers,
involving human subjects that do not involve human subjects that fall into
a class of subjects covered by 45 CFR Part 46, Subpart B, C, or D and are
not exempt from the Common Rule. The NIST IRB reviews such projects in
accordance with the procedures and criteria set out in 15 CFR Part 27 and
the NIST IRB Charter, which may be found in NIST Administrative Manual
Subchapter 3.01, Appendix A, and submits approved projects through the
Deputy Chief Counsel to the NIST Deputy Director. The NIST IRB may not
review projects involving the protected classes of human subjects covered
in 45 CFR Part 46, Subpart B, C, or D.
e. NIST IRB Chairperson:
(1) Advises OU Directors, upon request, as to possible exemptions available
under Common Rule for specific research projects identified in paragraph
14.01.04a. above.
(2) Determines whether expedited or full review of an internal research
project is appropriate, and convenes the NIST IRB, as provided in the Common
Rule and in the NIST IRB Charter.
(3) In addition to NIST IRB responsibilities, is responsible for completing
NIST's final review of external research covered by the Common Rule that
has been approved by an outside IRB. Outside IRB review of a research project
is required whenever the research will be conducted by any organization
outside of NIST, whether under a grant, contract, cooperative agreement,
CRADA, or other formal or informal arrangement with NIST. The NIST IRB
Chairperson will work closely during this review with, and will obtain
the clearance of, all interested parties, including the Office of the General
Counsel's Office of Finance and Litigation and the NIST Deputy Chief Counsel.
The Chairperson submits approved projects through the Deputy Chief Counsel
to the NIST Deputy Director. The Chairperson may not approve the research
if it has not been approved by an IRB.
(4) Retains all records pertaining to research projects conducted or
supported by NIST in accordance with 15 CFR Part 27 and all research found
to be exempt in accordance with paragraph 14.01.05b.
(5) Prepares and submits to the NIST Deputy Director annually a report
on the activities of the NIST IRB, the NIST IRB Chairperson, and other
developments in the area of research involving human subjects.
f. NIST Deputy Chief Counsel:
(1) Reviews for legal sufficiency OU Director determinations that projects fall within an exemption to the Common Rule.
(2) Reviews for legal sufficiency IRB approvals of all research projects
conducted or supported by NIST involving human subjects that are not exempt
from the Common Rule prior to their submission to the NIST Deputy Director
for approval.
(3) Reviews for legal sufficiency assurances submitted to the NIST Deputy
Director by outside IRBs.
(4) Assists NIST personnel in determining appropriate review procedures
for human subjects research projects not clearly covered by procedures
set out in this subchapter.
(5) Serves as an ex officio member of the NIST IRB. The Deputy Chief
Counsel may assign this duty to a member of his/her staff.
g. NIST Deputy Director:
(1) Approves/disapproves all research projects conducted or supported
by NIST involving human subjects that are not exempt from the Common Rule.
The Deputy Director may not approve research projects not approved by a
qualified IRB.
(2) In consultation with the Deputy Chief Counsel, approves/disapproves
assurances submitted by outside IRBs that do not have current, appropriate
OPRR assurances.
14.01.06
PROCEDURES
a. Projects involving internal NIST research using human subjects
- If a research project is expected to involve human subjects, and the
work will be performed at NIST, the principal investigator must develop
a package to be submitted through line management to the OU Director, within
whose OU the project will be performed, for determination as to whether
the human subjects involved fall into a class of subjects covered by 45
CFR Part 46, Subpart B, C, or D and, if not, whether the project fits within
an exemption to the Common Rule.
(1) If the OU Director determines that the project involves human subjects
that fall into a class of subjects covered by 45 CFR Part 46, Subpart B,
C, or D:
(a) The project must be submitted to an IRB outside of NIST that possesses
a current assurance, appropriate for the research in question, on file
with OPRR, and that has received OPRR's approval for federalwide use. The
outside IRB must document to NIST that it possesses a current assurance,
appropriate for the research in question, on file with OPRR, and that it
has received OPRR's approval for federalwide use. This documentation must
be submitted to the NIST IRB Chairperson, who will confirm the outside
IRB's OPRR approval.
(b) When the NIST principal investigator has received approval from
the outside IRB, he/she will submit the entire package, including the documentation
of OPRR approval, the protocol description, and the outside IRB's approval
of the project, to the NIST IRB Chairperson
(c) Upon receipt of the package, the NIST IRB Chairperson will complete
NIST's final review of the outside IRB's certification of the project,
in accordance with 15 CFR 27.112. The outside IRB will be informed of any
outstanding issues regarding protection of human subjects. When all issues
have been resolved to the satisfaction of the NIST IRB Chairperson, the
NIST IRB Chairperson, with the concurrence of the Deputy Chief Counsel,
will submit the project to the NIST Deputy Director recommending approval.
(d) When the principal investigator has received notice of the NIST
Deputy Director's approval, the work may proceed.
(2) If the OU Director determines that the human subjects involved do
not fall into a class of subjects covered by 45 CFR Part 46, Subpart B,
C, or D and that the project is exempt, the OU Director must notify the
NIST IRB Chairperson with concurrence of the Deputy Chief Counsel, in accordance
with paragraph 14.01.05b. of this subchapter. When the principal investigator
receives a copy of the exemption memorandum from the OU Director, the work
may proceed.
(3) If the OU Director determines that the human subjects involved do
not fall into a class of subjects covered by 45 CFR Part 46, Subpart B,
C, or D, and the project is not exempt from the Common Rule:
(a) The project must be submitted to the NIST IRB. A list of documentation
that must be provided to the NIST IRB may be found in Appendix B of this
subchapter. The NIST IRB Chairperson will determine whether the project
is appropriate for full or expedited review in accordance with the NIST
IRB Charter and the Common Rule. NIST IRB procedures and criteria for project
approval may be found in the NIST IRB Charter, NIST Administrative Manual
Subchapter 3.01, Appendix A.
(b) The NIST IRB Chairperson will work with the principal investigator
of the project to bring the project into compliance with the Common Rule.
When the project has met all the criteria and is approved by the NIST IRB,
the NIST IRB Chairperson, with the concurrence of the Deputy Chief Counsel,
will submit the project to the NIST Deputy Director recommending approval.
(c) When the principal investigator has received notice of the NIST
Deputy Director's approval, the work may proceed.
(4) Continuing Review.
(a) The NIST IRB Chairperson will contact the NIST principal investigator
at appropriate intervals to conduct continuing review of the research originally
reviewed by the NIST IRB to ensure that projects remain in compliance with
15 CFR Part 27.
(b) For projects conducted under 45 CFR Part 46, Subpart B, C, or D,
the NIST principal investigator will follow the continuing review procedures
imposed by the IRB that certified the project.
b. NIST-funded or supported projects involving external research
using human subjects, and research conducted at NIST under proprietary
and non-proprietary facilities use agreements - If a research project
is expected to involve human subjects, and the work involving human subjects
will be performed outside NIST through either a grant, a contract, or a
cooperative agreement used as the funding mechanism, or if a project involving
human subjects will be performed at NIST by an outside organization under
a facilities use agreement (either proprietary or non-proprietary), the
NIST principal investigator must develop a package to be submitted through
line management to the OU Director whose OU will fund the project, or in
which the facility is located, for determination as to whether the human
subjects involved fall into a class of subjects covered by 45 CFR Part
46, Subpart B, C, or D, and, if not, whether the project fits within an
exemption to the Common Rule.
(1) If the OU Director determines that the project involves human subjects
that fall into a class of subjects covered by 45 CFR Part 46, Subpart B,
C, or D, the procedures detailed in paragraph a.(1) of this section must
be followed.
(2) If the OU Director determines that the human subjects involved do
not fall into a class of subjects covered by 45 CFR Part 46, Subpart B,
C, or D and that the project is exempt, the OU Director must notify the
NIST IRB Chairperson, with concurrence of the Deputy Chief Counsel, in
accordance with paragraph 14.01.05b. When the prinicipal investigator receives
a copy of the exemption memorandum, the award may be processed or the agreement
executed, and the work may proceed.
(3) If the OU Director determines that the human subjects involved do
not fall into a class of subjects covered by 45 CFR Part 46, Subpart B,
C, or D, and that the project is not exempt from the Common Rule:
(a) The institution that will conduct the research involving human subjects
must provide to NIST documentation that the project has received approval
from an IRB outside NIST. The outside IRB conducting the review must submit
appropriate documentation to NIST under either (i) or (ii) below. For all
projects involving protected classes of subjects covered by 45 CFR Part
46, Subparts B, C, or D, reviews may only be conducted by IRBs that possess
current, appropriate assurances from OPRR; therefore, only (i) applies
to such projects.
(i) The outside IRB may document to NIST that it possesses a current
assurance, appropriate for the research in question, on file with the OPRR,
and that it has received OPRR's approval for federalwide use. If the outside
IRB documents to NIST that it possesses a current assurance, appropriate
for the research in question, on file with OPRR, and that it has received
OPRR's approval for federalwide use, the entire package, including this
documentation, the protocol description, and the outside IRB's approval
of the project, must be submitted to the NIST IRB Chairperson who will
confirm the outside IRB's OPRR approval.
(ii) The outside IRB may submit to the NIST Deputy Director assurances,
as described in 15 CFR 27.103, showing its compliance with the Common Rule.
The Deputy Director will evaluate all such assurances, in consultation
with the Deputy Chief Counsel, through such officers and employees of NIST
and such experts or consultants engaged for this purpose as he/she deems
to be appropriate. If the NIST Deputy Director approves the outside IRB's
assurances, he/she will notify the principal investigator in writing and
will forward the entire package, including the assurances submitted, his/her
approval of such assurances, the protocol description, and the outside
IRB's approval of the project to the NIST IRB Chairperson.
(b) Upon receipt of the package, the NIST IRB Chairperson will complete
NIST's final review of the outside IRB's certification of the project,
in accordance with 15 CFR 27.112. The outside IRB will be informed of any
outstanding issues regarding protection of human subjects. When all issues
have been resolved to the satisfaction of the NIST IRB Chairperson, the
NIST IRB Chairperson, with the concurrence of the Deputy Chief Counsel,
will submit the project to the NIST Deputy Director recommending approval.
(c) When the principal investigator has received notice of the NIST
Deputy Director's approval, the award may be processed or the agreement
executed, and work on the project may proceed.
(4) The Chief, Acquisition and Assistance Division, or designee, will
contact contractors, grantees, and cooperative agreement funding recipients
whose projects involve human subjects research at appropriate intervals
to ensure that their projects are receiving continuing review by an appropriate
IRB in accordance with their special award conditions and 15 CFR Part 27.
The Director, Office of Technology Partnerships, will contact organizations
who have executed facilities use agreements involving human subjects research
at appropriate intervals to ensure that their projects are receiving continuing
review by an appropriate IRB in accordance with the continuing review procedures
imposed by the IRB that certified the project.
c. Cooperative research projects (CRADAs, 1525 Agreements, cooperative agreements where NIST participation rises to the level of NIST participation in the research, or other formal or informal cooperative research arrangements) - Cooperative research projects are those projects covered by the Common Rule which involve more than one institution. Except as provided in paragraph d. below, if a cooperative research project is expected to involve human subjects, the NIST principal investigator must develop a package to be submitted through line management to the OU Director whose OU will participate in the research for determination as to whether the human subjects involved fall into a class of subjects covered by 45 CFR Part 46, Subpart B, C, or D and, if not, whether the project fits within an exemption to the Common Rule.
(1) If the OU Director determines that the project involves human subjects
that fall into a class of subjects covered by 45 CFR Part 46, Subpart B,
C, or D, the procedures detailed in paragraph a.(1) of this section must
be followed.
(2) If the OU Director determines that the human subjects involved do
not fall into a class of subjects covered by 45 CFR Part 46, Subpart B,
C, or D and that the project is exempt, the OU Director must notify the
NIST IRB Chairperson, with concurrence of the Deputy Chief Counsel, in
accordance with paragraph 14.01.05b. When the prinicipal investigator receives
a copy of the exemption memorandum, the agreement may be processed, and
the work may proceed.
(3) If the OU Director determines that the humans subjects involved do not fall into a class of subjects covered by 45 CFR Part 46, Subpart B, C, or D, and the cooperative research project involving human subjects is not exempt from the Common Rule, each institution involved in the research is responsible for safeguarding the rights and welfare of human subjects and for complying with the Common Rule. Specifically, (i) portions of cooperative research involving human subjects that will be performed at NIST by NIST employees must be reviewed by the NIST IRB in accordance with the procedures set out in paragraph 14.01.06a. of this subchapter, the Common Rule, and the NIST IRB Charter; and (ii) portions of cooperative research involving human subjects that will be performed outside NIST, or that will be performed at NIST by non-NIST personnel, must be reviewed by an outside IRB that has NIST approval to conduct the review in accordance with paragraph 14.01.06b.(3)(a) of this subchapter and the Common Rule. Upon receipt of the entire package, including documentation of OPRR approval or assurances submitted to the NIST Deputy Director and his/her approval of such assurances, the protocol description, and the outside IRB's approval of the project, the NIST IRB Chairperson will complete NIST's final review of the research in accordance with 15 CFR 27.112. The outside IRB will be informed of any outstanding issues regarding protection of human subjects.
(4) When all issues involving all portions of the project have been
resolved to the satisfaction of the NIST IRB Chairperson, the NIST IRB
Chairperson, with the concurrence of the Deputy Chief Counsel, will submit
the project to the NIST Deputy Director recommending approval.
(5) When the principal investigator has received notice of the NIST
Deputy Director's approval, the work on the project may proceed.
(6) The Chief, Acquisition and Assistance Division, the Chief, Finance Division, or the Director, Office of Technology Partnerships, or designee, as appropriate, will contact the institutions participating with NIST in joint research projects involving human subjects at appropriate intervals to ensure that their projects are receiving continuing review by an appropriate IRB in accordance with their special award conditions and 15 CFR Part 27.
d. Human subjects research projects conducted under certain on-going cooperative research arrangements, including CARB and JILA - When appropriate, the Deputy Director may enter into joint review arrangements, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort, as permitted by 15 CFR 27.114, for projects involving human subjects research that are conducted under on-going cooperative research arrangements, such as CARB or JILA.
e. Human subjects research conducted under a foreign or domestic
guest researcher agreement:
(1) If a project involving human subjects research is to be conducted
under a guest researcher agreement and the research is supported by NIST
funding, the project must receive appropriate exemptions or approvals as
described in paragraph a. of this section.
(2) If a project involving human subjects research is to be conducted
under a guest researcher agreement and the research is funded by another
federal agency, the project must receive appropriate exemptions or approvals
as described in paragraph b. of this section.
f. If a project involving human subjects is not clearly covered in the
preceding paragraphs, the NIST principal investigator and his line management
must work with the Deputy Chief Counsel or designee to determine appropriate
review procedures for the project.
14.01.07
RECORDKEEPING
a. The NIST IRB Chairperson will retain official files containing
documentation of all communications, reviews, clearances, and approvals/disapprovals
concerning exemptions, projects submitted to the NIST IRB, assurances submitted
to NIST by outside IRBs, outside IRB possession of current OPRR assurances,
and NIST-supported projects reviewed by outside IRBs.
b. The Chief, Acquisition and Assistance Division, for all contracts,
grants, and cooperative agreements that involve human subjects research;
the Chief, Finance Division, for all 1525 agreements and other formal
or informal agreements processed through the Chief, Finance Division that
involve human subjects research; the Director, Office of Technology
Partnerships, for all CRADAs, domestic guest researcher agreements
and other formal or informal agreements processed through the Industrial
Partnerships Program; and the Director, Office of International and
Academic Affairs, for all foreign guest researcher agreements involving
human subjects research are responsible for ensuring that the files retained
in their offices contain appropriate documentation of clearances and approvals
concerning exemptions and IRB reviews of projects.